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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04308005
Other study ID # SONUR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2013
Est. completion date October 2015

Study information

Verified date March 2020
Source Trakya University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In the present study, we aimed to assess children's anxiety levels by using different dental anxiety scales and children's drawings evaluated according to two different scoring systems: Child Drawing: Hospital (CD: H) and Emotional indicators of Human Figure Drawings (HFD).


Description:

Background: Drawings can be used as a method of communication that represents an individual's self-concept, anxiety, attitude, or conflict.

Aim: The purpose of this study was to evaluate children's drawing as a measure of dental anxiety in a dental setting.

Design: Seventy- eight children, aged 6-12 years, were enrolled in this study. Pulp therapy and/or restorative treatment was performed during the first therapeutic session for all participants. Sound, Eye, and Motor (SEM) and Frankl scales were used as an objective assessment of dental anxiety during treatment. After the treatment session, the children were instructed to draw a picture of a person at a dental clinic. Children's drawings were scored by a paediatric dentist and a psychologist using Child Drawing: Hospital (CD: H) scale and emotional indicators of Human Figure Drawings (HFD). The findings were compared with Frankl and SEM scores.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date October 2015
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria:

- 6-12 years of age-independent of sex, and ethnic characteristics

- Children without previous dental treatment experience.

- Children with carious primary teeth which required pulp therapy and restorative treatment

- Children who are not considered medically compromised

- Obtained written informed consent from parents or caregivers and obtained verbal informed consent from the child for their participance in the study where procedures are explained in an age-appropriate attitude

- Children who accept to draw a picture

Exclusion Criteria:

- Children with a compromised physical and mental health history

- Children who already received dental treatments

- Children who only needed preventive treatments

- Children who reject to draw a picture

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Trakya University Yeditepe University

Outcome

Type Measure Description Time frame Safety issue
Primary Child Drawing: Hospital (CD: H) scale Children's drawings were scored by a paediatric dentist and a psychologist using Child Drawing: Hospital (CD: H) scale.CD: H Scoring Guide, Rating Scale and the CD: H score sheet was used for the scoring of the drawings.A manual has been established to aid in scoring the drawing, which consists of specific directions and examples to assist in scoring the drawing. Raters were directed to read and understand the CD: H manual carefully, which includes the CD: H Scoring Guide and Rating Scale and the CD: H Score Sheet.The scoring of the drawing consists of three sections. Level of anxiety according to CD: H score sheet was as follows.27 <43: very low stress, 44-83: low stress, 84-129: average stress, 130-167: above average; and 168 and over: very high stress. 1 hour
Primary Human Figure Drawings (HFD) Children's drawings were scored by a paediatric dentist and a psychologist usingemotional indicators of Human Figure Drawings (HFD).Thirty clinically valid emotional indicators (EIs) consisting of 9 quality signs, 13 special features, and eight omissions.Drawings are analyzed by the presence or absence of EIs. Score EIs as 1 = present or 0 = absent, and a total score is achieved by adding all scores that can be used in statistical analysis. Drawings can be quickly evaluated for evidence of EIs which are signs on HFDs that are associated with specific traits, anxieties.For instance, insecure and anxious children prefer to draw small figures. Moreover, children with anxiety tend to shade parts of the figure.Two or more EIs imply possible emotional difficulties exhibited by the child that warrant further investigation. 1 hour
Primary Frankl Scale Frankl scale was used as an objective assessment of behaviour during treatment.The Frankl scale is rated according to the following criteria: Rating score 1: definitely negative: Refusal of treatment, crying forcefully, fearful or any other overt evidence of extreme negativism; Rating score 2: negative: Reluctant to accept treatment, uncooperative, some evidence of negative attitude but not pronounced, that is sullen, withdrawn; Rating score 3: positive: acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's direction cooperatively; Rating score 4: definitely positive: good rapport with the dentist, interested in dental procedures, laughing and enjoying the situation. 1 hour
Primary Sound, Eye, and Motor (SEM) scale Sound, Eye, and Motor (SEM) and Frankl scales were used as an objective assessment of behaviour during treatment.The slightest manifestation of the eyes, sound or motion of the patient is graded in four levels: comfort, slight discomfort, moderate pain, and pain. Rating scores range from 1 to 4. Lowest score represent comfort whereas high score indicate pain. 1 hour
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